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Plan B

FDA rejected Plan B drug well before data review

Monday, August 07, 2006 by: NewsTarget
Tags: Plan B, the FDA, junk science


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(NewsTarget) Two FDA officials say the administration's decision to deny over-the-counter access to Plan B -- commonly known as the morning after pill -- was made well before FDA scientists completed their final review of the contraceptive.

Dr. John Jenkins, director of the FDA's Office of New Drugs, said in recently released court documents that early in 2004, then-Commissioner Mark McClellan decided to reject Plan B long before the scientific review of the drug was finished. The FDA rejected Plan B in May 2004, just after McClellan left the agency.

"I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins said.

McClellan said in a sworn statement in June, "If I was being given any direction on how I should act on this application, I would have remembered that because that never happened."

Another FDA employee, Dr. Florence Houn, said Deputy Commissioner Dr. Janet Woodcock told her in January that Plan B must be rejected "to appease the administration's constituents." Supporters of making Plan B available over the counter allege that the FDA caved in to pressure from the Bush administration, which disapproves of the pill.

FDA officials say Plan B was rejected because of insufficient data on whether or not the drug could be safely used by younger girls. Critics of the FDA say the agency's early decision on Plan B indicates a trend within the agency of caving to political pressure instead of making sound scientific drug decisions to protect public health.

"This new evidence describing the true motivations behind the FDA's decision on Plan B indicates, yet again, that the agency is driven by politics, not science," said Mike Adams, consumer health advocate and frequent critic of the FDA. "As with many prescription drugs, FDA officials had already decided their course of action well before the scientific data were reviewed."

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